Harm Reduction With Pharmacotherapy (HaRP)

NCT01932801 ↗

Phase 2 Completed 308 enrolled University of Washington Alkermes, Inc. · collab National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this study is to test the efficacy of extended-release naltrexone and harm reduction counseling in reducing alcohol-related harm among homeless people with alcohol dependence.

Timeline

Start: 2013-08-01
Primary completion: 2018-10-11
Completion: 2019-06-30

Outcome

Met primary endpoint

registry p = .01; Slope -.48 (95% CI -.79 to -.18); z score for parameters NCT01932801 ↗

registry p = .002; Slope -2.22 (95% CI -3.39 to -1.06); z NCT01932801 ↗

registry p = .047; Slope -4.42 (95% CI -8.09 to -.76); z NCT01932801 ↗

Publications

Background Collins SE, Saxon AJ, Duncan MH, Smart BF, Merrill JO, Malone DK, Jackson TR, Clifasefi SL, Joesch J, Ries RK. Harm reduction with pharmacotherapy for homeless people with alcohol dependence: protocol for a randomized controlled trial. Contemp Clin Trials. 2014 Jul;38(2):221-34. doi: 10.1016/j.cct.2014.05.008. Epub 2014 May 17.
Background Collins SE, Duncan MH, Saxon AJ, Taylor EM, Mayberry N, Merrill JO, Hoffmann GE, Clifasefi SL, Ries RK. Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial. Lancet Psychiatry. 2021 Apr;8(4):287-300. doi: 10.1016/S2215-0366(20)30489-2. Epub 2021 Mar 10.
Background Fentress TSP, Wald S, Brah A, Leemon G, Reyes R, Alkhamees F, Kramer M, Taylor EM, Wildhood M, Frohe T, Duncan MH, Clifasefi SL, Collins SE. Dual study describing patient-driven harm reduction goal-setting among people experiencing homelessness and alcohol use disorder. Exp Clin Psychopharmacol. 2021 Jun;29(3):261-271. doi: 10.1037/pha0000470.
Background Goldstein SC, Spillane NS, Tate MC, Nelson LA, Collins SE. Measurement invariance and other psychometric properties of the Short Inventory of Problems (SIP-2R) across racial groups in adults experiencing homelessness and alcohol use disorder. Psychol Addict Behav. 2023 Mar;37(2):199-208. doi: 10.1037/adb0000833. Epub 2022 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	380 mg	Intramuscular